Spinal Cord InjuryBCSCINCT07008157
Rehabilitation Program for Bladder Control in Individuals With Incomplete Spinal Cord Injury
A study testing 1. IFC, 2. Timed voiding. and motor imagery training in people with Spinal Cord Injury, run by Cairo University at 1 site in Egypt.
Trial summary
This prospective, randomized, double-blind clinical trial (with both participants and outcome assessors blinded to group assignments) was carried out at the outpatient clinic of the Faculty of Physical Therapy, Cairo University, following patient referrals. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- 1. IFC, 2. Timed voiding. and motor imagery training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 16 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals between 18 and 65 years of age
- presenting with OAB symptoms
- diagnosed with ISCI classified as AIS C or D above the L1 spinal level
Who cannot join
- complete spinal cord injury
- current urinary tract infections
- a history of pelvic malignancy
- prior bladder or pelvic surgeries
- significant cognitive or psychiatric disorders
Trial locations and contacts
1 site in 1 country.
Egypt1 site
faculty of physical therapy, Cairo University
Cairo, Cairo Governorate, P.O.Box 11432
About this study
Official title: Efficacy of a Multimodal Conservative Rehabilitation Program for Bladder Control in Individuals With Incomplete Spinal Cord Injury: A Randomized Controlled Trial
This prospective, randomized, double-blind clinical trial (with both participants and outcome assessors blinded to group assignments) was carried out at the outpatient clinic of the Faculty of Physical Therapy, Cairo University, following patient referrals. Participants were recruited between October 2024 and April 2025 from the National Institute of Urology and Nephrology in Mataria, as well as the Department of Urology and Nephrology at Kasr Alaini Hospital. All diagnoses were verified by a consultant urologist. The study received ethical approval from the Institutional Review Board of the Faculty of Physical Therapy, Benha University, Egypt, and written informed consent was obtained from each participant prior to enrollment.
Participants Individuals between 18 and 65 years of age presenting with OAB symptoms, confirmed through urodynamic testing, and diagnosed with ISCI classified as AIS C or D above the L1 spinal level, were considered eligible for inclusion in this study. Participants were required to be medically stable, able to follow study protocols, and willing to provide informed consent. Exclusion criteria included those with complete spinal cord injury (AIS A), current urinary tract infections, a history of pelvic malignancy, prior bladder or pelvic surgeries, or significant cognitive or psychiatric disorders.
Read the detailed description
This prospective, randomized, double-blind clinical trial (with both participants and outcome assessors blinded to group assignments) was carried out at the outpatient clinic of the Faculty of Physical Therapy, Cairo University, following patient referrals. Participants were recruited between October 2024 and April 2025 from the National Institute of Urology and Nephrology in Mataria, as well as the Department of Urology and Nephrology at Kasr Alaini Hospital. All diagnoses were verified by a consultant urologist. The study received ethical approval from the Institutional Review Board of the Faculty of Physical Therapy, Benha University, Egypt, and written informed consent was obtained from each participant prior to enrollment.
Participants Individuals between 18 and 65 years of age presenting with OAB symptoms, confirmed through urodynamic testing, and diagnosed with ISCI classified as AIS C or D above the L1 spinal level, were considered eligible for inclusion in this study. Participants were required to be medically stable, able to follow study protocols, and willing to provide informed consent. Exclusion criteria included those with complete spinal cord injury (AIS A), current urinary tract infections, a history of pelvic malignancy, prior bladder or pelvic surgeries, or significant cognitive or psychiatric disorders. Simple randomization was applied to allocate participants into one of two groups: the EG, which received IFC, PFMT, motor MIT, and timed voiding (TV); and the CG, which received IFC, PFMT, and TV. The randomization process involved a computer-generated sequence created using dedicated software to ensure an equal number of participants in each group. Allocation concealment was maintained by placing group assignments in sealed, opaque envelopes, which were opened sequentially as participants were enrolled in the study.
Outcome Measures
- Urodynamic assessments
- The International Consultation on Incontinence Questionnaire - Short Form (ICIQ-UI SF)
- PFM strength Treatment procedures
- IFC therapy 2. Timed voiding. 3. Motor imagery Training 4. PFMT
- Conditions
- Spinal Cord Injury
- Being tested
- 1. IFC, 2. Timed voiding., motor imagery training, pelvic floor muscles training
- Keywords
- Rehabilitation Program, Bladder Control, Incomplete Spinal Cord Injury
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1. IFCOther
IFC therapy was applied while the patient lay in a supine position with the knees slightly apart. Each treatment session involved four electrodes enclosed in lint cloth covers. Two electrodes were positioned bilaterally on the lower abdomen, just below the anterior superior iliac spines (ASIS), while the remaining two were placed on the inner surfaces of both thighs. To maintain hygienic standards, the cloth covers were replaced for each participant at every session. The intervention was administered three times weekly over an eight-week period. A frequency range of 0-10 Hz was used, and the current intensity was carefully adjusted based on each patient's comfort and tolerance. Each IFC session lasted 15 minutes, with the aim of modulating pelvic region activity to support improved bladder function. This protocol was implemented three times per week over an eight-week period
2. Timed voiding.Other
The approach involved instructing participants to follow a fixed, scheduled voiding routine, typically every 3 hours, irrespective of the sensation to urinate. Additionally, patients were advised to adjust their toileting posture by sitting and leaning forward at an angle of approximately 45 degrees, allowing adequate time for complete bladder emptying. The technique also included practicing double voiding, where the individual would stand up and sit down again after the initial void to help ensure maximum bladder evacuation
motor imagery trainingOther
Prior to initiating MIT, participants watched a 10-minute instructional video in a quiet treatment space, illustrating proper PFM contractions through both visual and auditory cues. The therapist provided a detailed explanation, using a simple analogy of the bladder as a balloon filled with urine, connected by a tube (the urethra) to the outside, and controlled by the PFM. It was explained that contracting these muscles tightens the balloon, holding back urine, whereas weak or relaxed muscles may lead to leakage. Patients were then guided to mentally visualize contracting and holding these muscles until they reached a suitable time and place (the toilet), without physically performing the action. Following this explanation, patients were asked to sit comfortably with their eyes closed and spend 10 minutes visualizing the movement and control of their PFM while remaining physically relaxed. Throughout the session, the therapist used open-ended prompts to help maintain the patient's focu
pelvic floor muscles trainingOther
Before beginning each treatment session, participants were instructed to empty their bladders to promote comfort and relaxation during the exercises. All patients were taught a structured PFMT routine, to be performed daily in multiple positions such as lying, sitting, and standing. The program consisted of contracting the PFM for 10 seconds, followed by a 10-second relaxation period, with this sequence repeated 15 times in each session. To gradually enhance the endurance of the slow-twitch muscle fibers, both contraction and relaxation times were increased by one second each week. In addition, to activate and strengthen the fast-twitch muscle fibers, patients were directed to perform 20 quick, repetitive contractions and relaxations of the levator ani muscles - simulating the act of stopping urine flow, followed by a 10-second rest. This rapid contraction sequence was repeated for 2 to 4 sets in each session. This protocol was implemented three times per week over an eight-week period
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | received IFC, PFMT, motor MIT, and timed voiding (TV)1. IFC interferential current, pelvic floor muscles training, timed voiding, and motor imagery training Receives: Other: 1. IFC; Other: 2. Timed voiding.; Other: motor imagery training; Other: pelvic floor muscles training |
| control group | Active comparator | participants received interferential current therapy, timed voiding, and pelvic floor muscles training Receives: Other: 1. IFC; Other: 2. Timed voiding.; Other: pelvic floor muscles training |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Urodynamic assessments
These evaluations were carried out by experienced clinicians to maintain consistency and accuracy, providing real-time measurements of bladder function in a controlled environment. The procedure involved positioning the patient either supine or seated, followed by the insertion of a sterile catheter through the urethra into the bladder for fluid instillation and pressure monitoring. During cystometric testing, the bladder was gradually filled with sterile saline at a steady rate, while intravesical and abdominal pressures were continuously recorded. Key parameters measured included MCC, LPP, and the bladder volume at the first sensation of the urge to void
Measured: at three time points: baseline, after 8 weeks of treatment, and at an 8-week follow-up
Body Mass Index
In this study, Body Mass Index (BMI) was used as an anthropometric measure to assess the weight status of patients with incomplete spinal cord injuries. BMI was calculated using the formula: BMI = weight (kg) / height² (m²). The classification of BMI values followed the guidelines established by the World Health Organization, where individuals with a BMI less than 18.5 kg/m² were considered underweight, those between 18.5-24.9 kg/m² were classified as having a normal weight, values from 25.0-29.9 kg/m² indicated overweight, and a BMI of 30.0 kg/m² or higher was categorized as obesity (World Health Organization, 2000).
Measured: baseline, after 8 weeks of treatment, and at an 8-week follow-up.
Secondary outcomes (1)
2. The International Consultation on Incontinence Questionnaire - Short Form (ICIQ-UI SF)
ICIQ-UI SF is a widely recognized, validated, and reliable tool designed to assess the severity of urinary incontinence and its effect on QOL. It has demonstrated strong validity and reliability, producing consistent, reproducible results across diverse clinical and research populations (Avery et al., 2004). In the present study, the ICIQ-UI SF was administered at three time points: baseline, after 8 weeks of intervention, and at an 8-week follow-up, in accordance with the study's schedule for evaluating changes in urinary symptoms and related QOL
Measured: at three time points: baseline, after 8 weeks of intervention, and at an 8-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start1 Oct 2024
- Primary completion16 Apr 2025
- Study completion16 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, randomized, double-blind clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hany Mohamed Ibrahim Elgohary, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07008157
- Sponsor's protocol ID
- PT.BU.EC.18
- Acronym
- BCSCI
- Status last verified
- May 2025
- First submitted
- 19 May 2025
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data will be available when required
Publications
Elfahl AM, Abd El Baky AM, Yousef MT, Elgohary HM. High Versus Low Frequency Transcutaneous Electric Nerve Stimulation On Chronic Venous Lower Limb Ulceration Randomized Controlled Trial. Int J Low Extrem Wounds. 2025 Jun;24(2):376-382. doi: 10.1177/15347346221093860. Epub 2022 Apr 14.
PubMed 35422171Elbalawy Y, Ibrahim ZM, Ibrahim Ali O, Elgohary HM. Efficacy of a multimodal conservative rehabilitation program for bladder control in individuals with incomplete spinal cord injury: A randomized controlled trial. J Int Med Res. 2026 Sep;54(9):3000605261464292. doi: 10.1177/03000605261464292. Epub 2026 Sep 8.
PubMed 42711095
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Multimodal Conservative Rehabilitation Program for Bladder Control in Individuals With Incomplete Spinal Cord Injury: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07008157
- Acronym / sponsor ID
- BCSCI / PT.BU.EC.18
- Conditions
- Spinal Cord Injury
- Keywords
- Rehabilitation Program, Bladder Control, Incomplete Spinal Cord Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 16 Apr 2025 (actual)
- Study completion
- 16 Apr 2025 (actual)
- First posted
- 6 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective, randomized, double-blind clinical trial (with both participants and outcome assessors blinded to group assignments) was carried out at the outpatient clinic of the Faculty of Physical Therapy, Cairo University, following patient referrals. Participants were recruited between October 2024 and April 2025 from the National Institute of Urology and Nephrology in Mataria, as well as the Department of Urology and Nephrology at Kasr Alaini Hospital. All diagnoses were verified by a consultant urologist. The study received ethical approval from the Institutional Review Board of the Faculty of Physical Therapy, Benha University, Egypt, and written informed consent was obtained from each participant prior to enrollment.
Participants Individuals between 18 and 65 years of age presenting with OAB symptoms, confirmed through urodynamic testing, and diagnosed with ISCI classified as AIS C or D above the L1 spinal level, were considered eligible for inclusion in this study. Participants were required to be medically stable, able to follow study protocols, and willing to provide informed consent. Exclusion criteria included those with complete spinal cord injury (AIS A), current urinary tract infections, a history of pelvic malignancy, prior bladder or pelvic surgeries, or significant cognitive or psychiatric disorders.
Detailed description
This prospective, randomized, double-blind clinical trial (with both participants and outcome assessors blinded to group assignments) was carried out at the outpatient clinic of the Faculty of Physical Therapy, Cairo University, following patient referrals. Participants were recruited between October 2024 and April 2025 from the National Institute of Urology and Nephrology in Mataria, as well as the Department of Urology and Nephrology at Kasr Alaini Hospital. All diagnoses were verified by a consultant urologist. The study received ethical approval from the Institutional Review Board of the Faculty of Physical Therapy, Benha University, Egypt, and written informed consent was obtained from each participant prior to enrollment.
Participants Individuals between 18 and 65 years of age presenting with OAB symptoms, confirmed through urodynamic testing, and diagnosed with ISCI classified as AIS C or D above the L1 spinal level, were considered eligible for inclusion in this study. Participants were required to be medically stable, able to follow study protocols, and willing to provide informed consent. Exclusion criteria included those with complete spinal cord injury (AIS A), current urinary tract infections, a history of pelvic malignancy, prior bladder or pelvic surgeries, or significant cognitive or psychiatric disorders. Simple randomization was applied to allocate participants into one of two groups: the EG, which received IFC, PFMT, motor MIT, and timed voiding (TV); and the CG, which received IFC, PFMT, and TV. The randomization process involved a computer-generated sequence created using dedicated software to ensure an equal number of participants in each group. Allocation concealment was maintained by placing group assignments in sealed, opaque envelopes, which were opened sequentially as participants were enrolled in the study.
Outcome Measures
- Urodynamic assessments
- The International Consultation on Incontinence Questionnaire - Short Form (ICIQ-UI SF)
- PFM strength Treatment procedures
- IFC therapy 2. Timed voiding. 3. Motor imagery Training 4. PFMT
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- prospective, randomized, double-blind clinical trial
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: 1. IFC, Other: 2. Timed voiding., Other: motor imagery training, Other: pelvic floor muscles trainingreceived IFC, PFMT, motor MIT, and timed voiding (TV)1. IFC interferential current, pelvic floor muscles training, timed voiding, and motor imagery training |
| control group | Active comparator | Other: 1. IFC, Other: 2. Timed voiding., Other: pelvic floor muscles trainingparticipants received interferential current therapy, timed voiding, and pelvic floor muscles training |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals between 18 and 65 years of age
Key exclusion criteria (5 listed)
- complete spinal cord injury
- current urinary tract infections
- a history of pelvic malignancy
- prior bladder or pelvic surgeries
- significant cognitive or psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1. IFCIFC therapy was applied while the patient lay in a supine position with the knees slightly apart. Each treatment session involved four electrodes enclosed in lint cloth covers. Two electrodes were positioned bilaterally on the lower abdomen, just below the anterior superior iliac spines (ASIS), while the remaining two were placed on the inner surfaces of both thighs. To maintain hygienic standards, the cloth covers were replaced for each participant at every session. The intervention was administered three times weekly over an eight-week period. A frequency range of 0-10 Hz was used, and the current intensity was carefully adjusted based on each patient's comfort and tolerance. Each IFC session lasted 15 minutes, with the aim of modulating pelvic region activity to support improved bladder function. This protocol was implemented three times per week over an eight-week period | Other | control group, experimental group |
| 2. Timed voiding.The approach involved instructing participants to follow a fixed, scheduled voiding routine, typically every 3 hours, irrespective of the sensation to urinate. Additionally, patients were advised to adjust their toileting posture by sitting and leaning forward at an angle of approximately 45 degrees, allowing adequate time for complete bladder emptying. The technique also included practicing double voiding, where the individual would stand up and sit down again after the initial void to help ensure maximum bladder evacuation | Other | control group, experimental group |
| motor imagery trainingPrior to initiating MIT, participants watched a 10-minute instructional video in a quiet treatment space, illustrating proper PFM contractions through both visual and auditory cues. The therapist provided a detailed explanation, using a simple analogy of the bladder as a balloon filled with urine, connected by a tube (the urethra) to the outside, and controlled by the PFM. It was explained that contracting these muscles tightens the balloon, holding back urine, whereas weak or relaxed muscles may lead to leakage. Patients were then guided to mentally visualize contracting and holding these muscles until they reached a suitable time and place (the toilet), without physically performing the action. Following this explanation, patients were asked to sit comfortably with their eyes closed and spend 10 minutes visualizing the movement and control of their PFM while remaining physically relaxed. Throughout the session, the therapist used open-ended prompts to help maintain the patient's focu | Other | experimental group |
| pelvic floor muscles trainingBefore beginning each treatment session, participants were instructed to empty their bladders to promote comfort and relaxation during the exercises. All patients were taught a structured PFMT routine, to be performed daily in multiple positions such as lying, sitting, and standing. The program consisted of contracting the PFM for 10 seconds, followed by a 10-second relaxation period, with this sequence repeated 15 times in each session. To gradually enhance the endurance of the slow-twitch muscle fibers, both contraction and relaxation times were increased by one second each week. In addition, to activate and strengthen the fast-twitch muscle fibers, patients were directed to perform 20 quick, repetitive contractions and relaxations of the levator ani muscles - simulating the act of stopping urine flow, followed by a 10-second rest. This rapid contraction sequence was repeated for 2 to 4 sets in each session. This protocol was implemented three times per week over an eight-week period | Other | control group, experimental group |
Primary outcome
1. Urodynamic assessments
Time frame: at three time points: baseline, after 8 weeks of treatment, and at an 8-week follow-up
These evaluations were carried out by experienced clinicians to maintain consistency and accuracy, providing real-time measurements of bladder function in a controlled environment. The procedure involved positioning the patient either supine or seated, followed by the insertion of a sterile catheter through the urethra into the bladder for fluid instillation and pressure monitoring. During cystometric testing, the bladder was gradually filled with sterile saline at a steady rate, while intravesical and abdominal pressures were continuously recorded. Key parameters measured included MCC, LPP, and the bladder volume at the first sensation of the urge to void
Body Mass Index
Time frame: baseline, after 8 weeks of treatment, and at an 8-week follow-up.
In this study, Body Mass Index (BMI) was used as an anthropometric measure to assess the weight status of patients with incomplete spinal cord injuries. BMI was calculated using the formula: BMI = weight (kg) / height² (m²). The classification of BMI values followed the guidelines established by the World Health Organization, where individuals with a BMI less than 18.5 kg/m² were considered underweight, those between 18.5-24.9 kg/m² were classified as having a normal weight, values from 25.0-29.9 kg/m² indicated overweight, and a BMI of 30.0 kg/m² or higher was categorized as obesity (World Health Organization, 2000).
1 secondary outcome
2. The International Consultation on Incontinence Questionnaire - Short Form (ICIQ-UI SF)
Time frame: at three time points: baseline, after 8 weeks of intervention, and at an 8-week follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Background: PubMed 35422171Elfahl AM, Abd El Baky AM, Yousef MT, Elgohary HM. High Versus Low Frequency Transcutaneous Electric Nerve Stimulation On Chronic Venous Lower Limb Ulceration Randomized Controlled Trial. Int J Low Extrem Wounds. 2025 Jun;24(2):376-382. doi: 10.1177/15347346221093860. Epub 2022 Apr 14.
- Derived from this study: PubMed 42711095Elbalawy Y, Ibrahim ZM, Ibrahim Ali O, Elgohary HM. Efficacy of a multimodal conservative rehabilitation program for bladder control in individuals with incomplete spinal cord injury: A randomized controlled trial. J Int Med Res. 2026 Sep;54(9):3000605261464292. doi: 10.1177/03000605261464292. Epub 2026 Sep 8.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. data will be available when required
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1. IFC, 2. Timed voiding. and motor imagery training in people with Spinal Cord Injury, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Urodynamic assessments (time frame: at three time points: baseline, after 8 weeks of treatment, and at an 8-week follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07008157, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.